Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-25
SponsorIslamabad Medical and Dental College
About this trial
Orthodontic separators are small devices placed between teeth before fitting braces to create space for bands. This procedure may cause pain, discomfort, and changes in oral hygiene, which can affect plaque buildup and daily activities.
This study aims to compare three commonly used types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of the amount of tooth separation achieved, pain experienced by patients, and plaque accumulation.
In addition, the study will assess how these separators affect patients' quality of life, including eating, speaking, and daily comfort.
Participants will be assigned to one of the three separator types and will be evaluated after 48 to 72 hours. The findings of this study may help identify the most effective and comfortable separator, improving patient care and treatment experience in orthodontics.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients requiring fixed orthodontic appliance therapy with maxillary first molar banding
Age between 12 and 25 years
Good oral hygiene (Plaque Index score 0-1)
Good general oral health
Disqualifiers
Presence of interproximal restorations
Presence of interproximal caries
Missing maxillary second premolar, first molar, or second molar
Unerupted maxillary second molars
Trial design
Design model
Parallel
Treatments tested in this trial
Elastomeric Separator
DeviceElastomeric separators are polyurethane O-shaped orthodontic modules placed interdentally between the mesial and distal surfaces of maxillary first molars. They exert continuous elastic force to create interproximal space prior to molar band placement. In this study, separators will be placed bilaterally and left in situ for 48-72 hours before removal and clinical assessment of separation, pain, and plaque accumulation.
Kesling Separator
DeviceKesling separators are spring-type orthodontic separators fabricated from 0.020-inch stainless steel Australian wire with a helical loop design. The appliance has two arms, one engaging the lingual embrasure and the other positioned beneath the interproximal contact point, providing controlled separation force in areas with tight contact. In this study, Kesling separators will be placed bilaterally on the mesial and distal surfaces of maxillary first molars and left in situ for 48-72 hours prior to removal and clinical evaluation of separation, pain, and plaque accumulation.
Tie wire separator
DeviceTie wire separators are orthodontic separators fabricated using 0.010-0.012 inch stainless steel ligature wire twisted and adapted interproximally around the contact area of posterior teeth. The wire is tightened and positioned to exert gradual separating force between the mesial and distal surfaces of maxillary first molars, facilitating creation of interproximal space for band placement. In this study, tie wire separators will be placed bilaterally and maintained in situ for 48-72 hours prior to removal and assessment of tooth separation, pain, and plaque accumulation.
Treatment groups
144 Participants
are divided into 3 treatment groupsGroup A: Elastomeric Separator GroupOther 2 interventions
Group B: Kesling Separator GroupActive comparator 2 interventions
Group C: Tie Wire Separator GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Amount of Tooth Separation Achieved
Interproximal separation between maxillary first molars measured using a leaf gauge (COMBO TECH incremental thickness gauge) on mesial and distal surfaces. Mean separation will be calculated.
Time frame
48 to 72 hours after separator placementSponsors and contacts
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Source ClinicalTrials.gov
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